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disposable surgical set

  • product description
  • performance and use

[product name] disposable operation bag.

[specifications and models] ordinary i type and type ii; interventional i type and type ii;

[name of registrant] henan jianqi medical equipment co. ltd.

the dingluan industrial zone in changyuan county.

[contact number] 0373-8690789.

[after-sales service unit] henan jianqi medical equipment sales co., ltd.

[name of production enterprise] henan jianqi medical equipment co., ltd.

the dingluan industrial zone in changyuan county.

[production address] dingluan industrial zone, changyuan county.

[contact information] 0373-8690789.

[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.

[registration certificate no.]

[technical requirements no.]


single, caesarean section in the structure and composition 】 【, single, treatment in disposable towels, gown, cloth, pharmacy, medical gloves, gauze pad with a syringe, mask, cap, gauze piece, cotton balls, scalpel, forceps, sponge brush, small bowl, square plate, etc. according to the different types of configuration.

[product performance] the operation package should be sealed well, with no gaps and no holes. all accessories should be free of damage, no stain, no impurities; the sewing parts should be sewn firmly, the needle code is uniform, straight, no crease, no jump needle, open line, leakage phenomenon; folded parts should be folded neatly. ; the sewing needle is no less than 8 needles within 3cm; the operating clothes should be free of mildew, no damage, no stains, no impurities; the needle code should be uniform, straight, no crease, no jump needle, open line and leak. the hot pressing of the operating clothes should be uniform, straight, no wrinkle, no leakage pressure; the material of the chest film (if any) is coated nonwovens, plastic films or nonwovens. the size should be no less than 40cm x 60cm. if it is not less than 35g/m2, the film should be flat, free of bubbles and dissociation. if there is plastic film on the sleeve, the plastic film should not be damaged, and the thickness of plastic film should be no less than 0.01mm; plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n; the surgical sleeves should be no less than 35g/m2, and the film should be flat, free of bubbles and separated. there is plastic film in the sleeve, the plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm. (if any); the fastness of sewing or hot pressing should be strong, and the strength should be greater than 10n. the rupture strength of each belt and the joint of the operating garment should be greater than 10n. the performance of the operating garment should meet the requirements of table 5; a fluorescent object of a suture.

according to the test a test in appendix d of yy 0594-2006, the suture should not show strong blue fluorescence; the total amount of soluble in water soluble in water should not exceed 0.50%. 2. single use should be a qualified product for obtaining medical device registration certificate. 3. the non-woven fabric specification shall be no less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. 4. disposable therapeutic towels shall be qualified products to obtain registration certificate of medical devices. 5. if the disposable medical bag cloth is made of hot pressure, the hot pressing part should be firm and not cracked; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. 6. disposable masks shall be qualified products for obtaining registration certificate of medical devices. 7. disposable syringes should be qualified products with medical device registration certificate. 8. disposable sterilized rubber surgical gloves shall be qualified products obtained from medical device registration certificate. 9. medical absorbent gauze pads shall be qualified products with medical device registration certificate. 10. a disposable hat shall be a qualified product for obtaining a medical device registration certificate. 11. the medical absorbent gauze piece shall be the qualified product for obtaining the medical device registration certificate. 12. the medical cotton ball shall be a qualified product for obtaining the medical device registration certificate. 13. sterile plastic handle scalpel should be qualified products with medical device registration certificate, or surface should be smooth, without obvious injection molding defect; the handle should be neat and clear; mark (if any) the mark on the plastic handle should be clear and complete; the surgical blades connected with the plastic handle shall be in accordance with the provisions of yy 0174-2005, 4.2, 4.3 and 4.4; the connection between blade and handle should be firm; there should be a blade protection device. 14. the medical tweezers should be symmetrical, and the appearance should be smooth, without front edge, burr, crack, pitting and trachoma. tweezers should have good elasticity; the two pieces of tweezers should be strong enough to withstand the tension of 15n without breaking. the teeth should be clear and complete, should not be missing teeth, bad teeth defects; the guiding pin and positioning pin of tweezers should be firmly fixed. when the tweezers are open and closed, they should be flexible and should not be jammed. the handle of the tweezers should be clear and complete. there should be no flowers or flowers. 15. the adhesive force of sponge head and brush is not less than 10n, and its joints should not be loose. 16. the appearance of small bowl should be smooth, without burr and injection flow; thickness should not be less than 0.01mm. 17. the square plate should be smooth, without burr and injection flow; thickness should not be less than 0.01mm. 18. disposable medical mats shall be qualified products with medical device registration certificate. 19. medical gauze bandages shall be qualified products for obtaining registration certificate of medical devices. 20. the sterile protective cover shall be a qualified product for obtaining the medical device registration certificate. 21. the medical suture needle shall be a qualified product for obtaining the medical device registration certificate. 22. non-absorbable surgical sutures shall be qualified products for obtaining registration certificate of medical devices. 23. self-adhesive wound care should be a qualified product to obtain medical device registration certificate. 24. the tourniquet should be a qualified product for obtaining the medical device registration certificate. 25. the shoe cover is made of non-woven fabric, plastic film or non-woven fabric, with no holes in the appearance; the shoe cover made of hot pressing should be straight, no leakage pressure, and fracture strength should not be less than 5n. 26. the elastic elongation ratio should be 1:2.2-1:3. the elastic recovery rate should be 75.0%; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 17.0n, and the transverse fracture strength should be greater than or equal to 3.0n; the film should not be less than 30g/m2, and the film should be flat, free of bubbles and separate phenomena. the plastic film shall not be damaged, and the thickness of the plastic film shall not be less than 0.01mm. 27. the coated non-woven fabric of the sleeve should not be less than 30g/m2, the film should be flat, free of bubbles and separate phenomena; the plastic film shall not be damaged, and the thickness of the plastic film shall not be less than 0.01mm; the elongation ratio of elastic band should be 1:2.2-1:3. the elastic recovery rate should be 75.0%; the sleeves made of hot pressure should be straight, no leakage pressure, and fracture strength should not be less than 5n. 28. the teeth of hemostatic forceps should be clear and should not be lacking of teeth, teeth and burrs. good elasticity and firmness. 29. the elastic bandage shall be a qualified product for obtaining the medical device registration certificate. 30. one-time use of attractive connecting pipe shall be a qualified product to obtain medical device registration certificate. 31. the name, specification and quantity of the items in the operation package shall conform to the requirements of table 1, table 2, table 3 and table 4. 32. sterile surgical kits should be sterile. 33. the residual amount of epoxy ethane was sterilized by ethylene oxide, and the residual amount of ethylene oxide should not be greater than 10ug/g.

[applicable scope] applicable to surgical operation of medical institutions.

contraindication: no absolute contraindication.

1. this product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.

2. see packaging seal or label on the production batch number, and the sterilization date is in the outer packing box.

3. this product is sterilized by ethylene oxide.

[use method] 1. select the applicable patient's specifications and model, and then open the package after the outer packing is in good condition.

2. take out the accessories according to the surgical needs.

3. after the product is finished, it should be treated with medical waste to avoid pollution.

[storage method] 1. this product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.

2. handle gently in handling and avoid violent collision;

3. the product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.

[production date] see packaging seal or label.

expiry date: see packaging seal or label.

[label, package logo]

[specification preparation date] february 7, 2017.


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